INON ACE- magnesium aluminosilicates, magnesium hydroxide, simethicone tablet

Inon Ace by

Drug Labeling and Warnings

Inon Ace by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)
Magnesium Aluminosilicates 200 mg
Magnesium Hydroxide 60 mg
Simethicone 20 mg

PURPOSE

Purposes
Magnesium Aluminosilicates    Antacid
Magnesium Hydroxide    Antacid
Simethicone    Antigas

INDICATIONS & USAGE

Uses relieves these symptoms

■heartburn ■acid indigestion ■sour stomach

■upset stomach and gas associated with these symptoms

WARNINGS

Enter section text here

Ask a doctor or pharmacist before use if you are

■taking a prescription drug. Antacids may interact with certain prescription drugs

When using this product

■Do not take more than 9 tablets in 24-hours period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions
■Adults and children 12 years of age and over: Take 3 tablets with water 3 times daily between meals and at bedtime, or as directed by a doctor.
■Children under 12 years: Ask a doctor.

OTHER SAFETY INFORMATION

Other information  
■Each tablet contains: sodium 8 mg, magnesium 35 mg
■Do not purchase if printed seal with “sato” is broken or missing from top or bottom of carton.

INACTIVE INGREDIENT

Inactive ingredients  caramel, colloidal silicon dioxide, croscarmellose sodium, flavor, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, synthetic iron oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INON ACE 
magnesium aluminosilicates, magnesium hydroxide, simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-402
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	60 mg
SILODRATE (UNII: 9T3UU8T0QK) (SILODRATE - UNII:9T3UU8T0QK)	SILODRATE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	brown (pale brown)	Score	no score
Shape	ROUND	Size	9mm
Flavor	PEPPERMINT, GINGER (ginger extract) , CINNAMON (cinnamon oil) , ANISE (fennel)	Imprint Code	SATO;6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-402-01	1 in 1 CARTON	11/01/1995
1		75 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	11/01/1995

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-402) , label(49873-402) , pack(49873-402)